Analytical Excellence

Accelerating Today’s Therapeutics

Leading global pharmaceutical organizations and emerging biopharma and gene and cell therapy companies trust ProtaGene’s analytical excellence, deep experience, and quality systems to accelerate and de-risk their therapeutic development programs.

scroll_down Created with Sketch.

Analytical Solutions from Research to Market

Our scientific expertise, experience across a wide range of therapeutics and regions, multi-continent foundation, and commitment to quality provide complete analytic solutions for protein biologics and gene and cell therapeutics throughout products’ development and regulatory life cycles—from discovery to market.

Group Created with Sketch.
Research
Preclinical
Group 2 Created with Sketch.

Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

Group 3 Created with Sketch.
Phase I
Phase II
Phase III
Group 4 Created with Sketch.

Phase I – Phase III

Release, Clinical Data and Characterization Packages for Accelerating Phase I-III Programs through BLA

Group Created with Sketch.
Registration
Market
Group 2 Created with Sketch.

Registration – Market

Commercial-Stage Comparability Testing by Qualified Advanced Methods

Biologic Drug
Analytics

Expertise in characterization, advanced method development, late-stage and GMP commercial sample testing under GMP, and complete data packages for all stages of biotherapeutic development—from clone to commercialization.

  • bullet Created with Sketch.

    mAbs

  • bullet Created with Sketch.

    Bispecifics/Multispecifics

  • bullet Created with Sketch.

    Recombinant Proteins—Including Complex, Highly Glycosylated Proteins

  • bullet Created with Sketch.

    Multi-subunit Complexes—Protein, Nucleotide, Ligand

  • bullet Created with Sketch.

    Fusion Proteins

  • bullet Created with Sketch.

    Enzyme Replacement Therapies

  • bullet Created with Sketch.

    ADCs and Protein Conjugates

  • bullet Created with Sketch.

    PEGylated Proteins

  • bullet Created with Sketch.

    Biosimilars

  • bullet Created with Sketch.

    Vaccines, Including Subunit/Recombinant

Gene and Cell Therapeutic Analytics

ProtaGene has led the industry in developing vector analytics advancing gene therapy safety, gene expression analysis, integration site analysis, genetic analytics, and related bioinformatics solutions.

Gene & Cell Therapeutic Platform Expertise

  • bullet Created with Sketch.

    Capsid-based Vectors

  • bullet Created with Sketch.

    Complex, Envelope Vectors

  • bullet Created with Sketch.

    Non-viral Vectors

  • bullet Created with Sketch.

    Genetic Engineering

Our Analytical Systems_Left Created with Sketch.

Our Analytical Systems

Enabled by state-of-the-art technology, ProtaGene offers an extensive range of analytical capabilities to support your biotherapeutic or gene & cell therapy projects.

Our Analytical Systems_right Created with Sketch.

Enhanced Partnerships Offer Strategic Expertise

Perhaps you need support to overcome a specific challenge, or maybe you’re looking for a close partnership throughout your product’s entire life cycle. ProtaGene’s CMC experts are here to help.

Img_MultipleCells_Pattern Created with Sketch.

Subscribe to Our Email List

Consent

Talk to Our Experts

Whether you are looking to learn more about our platforms or get a project started, contact our team today to discover how ProtaGene can support your development programs.

Contact Us